Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Investor Presentation (November 2016)
41 slides from Heron Therapeutics's investor presentation, November 2016
Slide 1: Company Update
Company Update November 2016
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. We caution investors that forward-looking statements are based on management’s expectations and assumptions as of the date of this presentation, and
Slide 3: Status of Product Portfolio
Status of Product Portfolio CINV Pain Preclinical Clinical NDA Approved SUSTOL® (granisetron) extended-release Now Approved by U.S. Food and Drug Administration injection 505(b)(2) Pathway: BE Study HTX-019 completed; Phase 2 & 3 studies Injectable IV NK1 for CINV Prevention should not be required;
Slide 4: SUSTOL Now Approved by U.S. FDA and on the Market
SUSTOL® Now Approved by U.S. FDA and on the Market U.S. Commercial Launch October 2016 4
Slide 5: Preventing CINV Remains a Significant Unmet Need
Preventing CINV Throughout Both Acute and Delayed Phases Remains a Significant Unmet Need Patients identified CINV as the side effect of % of MEC/HEC patients with breakthrough chemotherapy they most wanted to avoid CINV despite prophylaxis Community practice observational study Least acceptable 70%
Slide 6: SUSTOL Indication
SUSTOL Indication SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy
Slide 7: AC-Based Regimens are Classified as Highly Emetogenic
AC-Based Regimens are Classified as Highly Emetogenic by National Clinical Practice Guidelines Highly Emetogenic Chemotherapy • AC combination chemotherapy* • Dacarbazine • Carmustine >250 mg/m2 • Doxorubicin >60 mg/m2 • Cisplatin • Epirubicin >90 mg/m2 NCCN • Cyclophosphamide >1,500 mg/m2 • Ifosfam
Slide 8: The Branded 5-HT3 Market (Aloxi) Consists of ~2.5 Million Units
The Branded 5-HT3 Market (Aloxi) Consists of ~2.5 Million Units Injectable 5-HT3 Receptor Antagonists for the Prevention of CINV Number of Vials Sold in the U.S. by Quarter 800,000 700,000 600,000 500,000 400,000 300,000 200,000 100,000 - Q1'13 Q2'13 Q3'13 Q4'13 Q1'14 Q2'14 Q3'14 Q4'14 Q1'15 Q2'15 Q
Slide 9: 93% of Palonosetron Units are Used Outside of Cisplatin
93% of Palonosetron Units are Used Outside of Cisplatin Total U.S. palonosetron Units (2015) 3.0 By Chemo Regimen 2.5 0.18 Units (Millions) 2.0 Cisplatin 1.5 Other Chemotherapy 2.35 1.0 0.5 0.0 Source: Intrinsiq 2013 (for Aloxi units); Symphony 2015 (for proportion of chemo that is cisplatin) 9
Slide 10: Our Target Market Can be Reached by a Small but Focused Commercial Team
Our Target Market Can be Reached by a Small but Focused Commercial Team Commercial launch is highly-targeted with two key phases Phase 1 Targets Highly-concentrated1 • 700K branded units (50%) in 70 practices (533 sites) Phase 1 Targets Value clinical advances over 1st (First 12-18 months) gener
Slide 11: Heron's Commercial Plans Address Potential Launch Barriers
Heron’s Commercial Plans Address Potential Launch Barriers for Providers, Patients, and Payers Objectives Action Plan • First and only 5-HT3 with advanced, extended-release technology Establish SUSTOL and 5-day CINV prevention in MEC and AC-based HEC regimens1,2 clinical value & • Robust in-office a
Slide 12: U.S. Commercial Organization
U.S. Commercial Organization U.S. Commercial Organization Marketing Sales Phase 1 Targets Market Access (First 12-18 months) ~1.4MM Units GPO Account Team Payer Account Team MSLs / Nurse Educators Source: Symphony SNR data 2015 12
Slide 13: HTX-019: IV Aprepitant
HTX-019: IV Aprepitant Polysorbate 80-Free NK1 Receptor Antagonist for CINV Prevention 13
Slide 14: HTX-019
HTX-019 • HTX-019 is a proprietary intravenous (IV) formulation of aprepitant, an NK1 receptor antagonist and is distinguished from EMEND IV®, the only IV NK1 receptor antagonist presently approved in the U.S., in that it does not contain polysorbate 80, which may cause infusion site reactions, hype
Slide 15: HTX-019 is Bioequivalent to EMEND IV
HTX-019 is Bioequivalent to EMEND IV for Both Aprepitant and Total Aprepitant Equivalents 15
Slide 16: HTX-019 (IV aprepitant) for CINV: BE Study Safety Results
HTX-019 (IV aprepitant) for CINV: BE Study Safety Results • 100 subjects received HTX-019 and EMEND IV in standard cross-over design HTX-019 EMEND IV SAFETY Events Patients Events Patients Total AEs 27 21% 54 28% AEs considered related 18 15% 52 28% SAEs 0 - 0 - Moderate AEs 0 - 6 2% AEs leading to
Slide 17: Post-Operative Pain Program
POST-OPERATIVE PAIN PROGRAM HTX-011: Bupivacaine + Meloxicam in Proprietary Polymer 17
Slide 18: The Ideal Therapeutic for Post-Operative Pain
The Ideal Therapeutic for Post- Operative Pain • The ideal therapeutic for post-operative pain would: – Significantly reduce pain for several days after surgery – Significantly reduce opioid use: • Reduce total amount of opioids consumed • Increase number of patients who NEVER need an opioid – Demon
Slide 19: Market Opportunity for HTX-011 in Post-Operative Pain Management
Market Opportunity for HTX-011 in Post-Operative Pain Management Procedures Requiring Post-Operative Pain Relief Post-Operative Pain Market Share 2016-20211 Last 12 Months2 35.0 32.5 3% 29.9 30.6 28.5 29.2 30.0 27.8 Procedures (Millions) 25.0 18% Bupivacaine 20.0 Ropivacaine 15.0 Bupivacaine 10.0 Li
Slide 20: Biochronomer Bupivacaine Produced Significant Reductions in Pain in Preclinical Models
Biochronomer® Bupivacaine Produced Significant Reductions in Pain in Preclinical Models1 Pig Post-Operative Pain Model Saline Control Biochronomer Bupivacaine Bupivacaine Liposome Injectable Suspension (2) 100.0 Percentage of Maximal Force (60 gm) Tolerated by 90.0 80.0 70.0 60.0 Animal 50.0 40.0 30
Slide 21: Local Anesthetics Exist in a Balance Between Water-Soluble and Lipid-Soluble Forms
Local Anesthetics Exist in a Balance Between Water-Soluble and Lipid-Soluble Forms Inflammation Produces an Acidic Environment Which Shifts the Balance to Ionized Form Unable to Penetrate Nerve Cell Membrane BUPH+ BUPN + H+ Outside membrane Nerve Cell Membrane Inside membrane BUPH+ BUPN + H+ • The a
Slide 22: HTX-011's Unique Combination Produced Marked Anesthesia through 72 Hours
HTX-011’s Unique Combination of Bupivacaine and Meloxicam Produced Marked Anesthesia through 72 Hours1 Pig Post-Operative Pain Model Saline Control Biochronomer Bupivacaine HTX-011 Bupivacaine Liposome Injectable Suspension (2) Biochronomer Meloxicam Percentage of Maximal Force (60 gm) Tolerated 100
Slide 23: HTX-011 Is the First and Only Long-Acting Anesthetic Addressing Pain and Inflammation
HTX-011 IS THE FIRST AND ONLY LONG-ACTING ANESTHETIC DESIGNED TO ADDRESS BOTH POST- OPERATIVE PAIN AND ACCOMPANYING INFLAMMATION 23
Slide 24: HTX-011 Study 208: Bunionectomy Study Design
HTX-011 Study 208: Bunionectomy Study Design Injection – Closed wound (Nerve Block) HTX-011A 200 mg Injection – Open wound (Infiltration) Injection – Closed wound (Nerve Block) HTX-011B 200 mg Injection – Open wound (Infiltration) Injection – Closed wound Bupivacaine Solution (Nerve Block) Saline In
Slide 25: HTX-011-208: Demographics
HTX-011-208: Demographics HTX-011A HTX-011B Bupivacaine Characteristic Parameter Saline 200mg 200mg Solution Age (Years) n 32 31 15 15 Mean 49.5 52.2 52.7 48 Minimum 20.0 20.0 36.0 24.0 Maximum 72.0 71.0 84.0 69.0 Gender n (%) Male 5 (15.6) 5 (16.1) 2 (13.3) 3 (20.0) Female 26 (81.3) 26 (83.9) 13 (8
Slide 26: HTX-011-208: Route of Administration Did Not Impact Efficacy
HTX-011-208: Route of Administration Did Not Impact Efficacy 160 140 120 Mean SPI 0-24 Hours 100 80 60 40 20 0 HTX-011B 200mg Infiltration HTX-011B 200mg Nerve Block Bupivacaine Solution 50mg • No significant difference between routes, with both routes of HTX-011B administration significantly better
Slide 27: HTX-011-208: Mean Pain Intensity Scores
HTX-011-208: Mean Pain Intensity Scores* HTX-011B Is Superior to the A Formulation** HTX-011B Is Our Phase 3 Clinical Candidate 8 7 Mean Pain Intensity Scores 6 5 4 3 2 1 0 0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 90 96 Hours HTX-011A 200mg HTX-011B 200mg Bupivacaine Solution 50mg Saline Placebo *
Slide 28: HTX-011B Via Nerve Block Is Significantly Better than Placebo or Bupivacaine
HTX-011-208: Mean Pain Intensity Scores* HTX-011B Via Nerve Block Is Significantly Better than Placebo or Bupivacaine Solution HTX-011B Via Nerve Block 8 SPI24-48 SPI48-72 H vs P: p=0.013 H vs P: p=0.291 7 H vs B: p=0.003 H vs B: p=0.178 6 Mean Pain Intensity 5 4 3 2 SPI0-24 SPI0-48 SPI0-72 SPI0-96
Slide 29: HTX-011B Via Open Wound Injection Is Significantly Better than Placebo or Bupivacaine
HTX-011-208: Mean Pain Intensity Scores* HTX-011B Via Open Wound Injection Is Significantly Better than Placebo or Bupivacaine Solution HTX-011B Via Injection 8 SPI24-48 SPI48-72 7 H vs P: p=0.162 H vs P: p=0.115 H vs B: p=0.037 H vs B: p=0.345 6 Mean Pain Intensity 5 4 3 2 SPI0-24 SPI0-48 SPI0-72 S
Slide 30: HTX-011-208: Secondary Endpoint Mean Use of Opioid Rescue Medication
HTX-011-208: Secondary Endpoint Mean Use of Opioid Rescue Medication Mean opioid Rescue Over Placebo Bupivacaine HTX-011B Percent Time (P) Solution (B) 200 mg Reduction 5.2mg 74%↓ v P 0 – 24 hours 20.3mg 15.9mg p<0.0001 v P P<0.0001 v B 67%↓ v B 13.3mg 57%↓ v P 0 – 48 hours 31.1mg 28.5mg p=0.0001 v
Slide 31: HTX-011-208: Secondary Endpoints - Time to First Opioid, Opioid-Free Patients
HTX-011-208: Secondary Endpoints -Mean Time to First Opioid Increased by 716% -Significant Increase in Opioid-Free Patients Placebo Bupivacaine HTX-011B (P) Solution (B) 200 mg Mean Time to 31.0hr First Opioid 3.8hr 11.6hr p<0.0001 vs P Rescue p=0.037 vs B Medication Percent of Patients Opioid 32% 0
Slide 32: HTX-011 Study 202: Herniorrhaphy Study Design
HTX-011 Study 202: Herniorrhaphy Study Design Injection HTX-011B 200mg Instillation Part B Injection HTX-011B 400mg Instillation Saline Injection 32
Slide 33: HTX-011-202B: Demographics
HTX-011-202B: Demographics HTX-011B HTX-011B Saline Part B Characteristic Parameter 200mg 400mg N = 31 N = 31 N = 30 Age (Years) Mean 45.2 44.3 44.8 Minimum 24 19 21 Maximum 67 79 62 Gender n (%) Male 31 (100) 23 (96) 30 (97) Female 0 (0) 1 (3) 1 (3) Race n (%) Caucasian 29 (94) 25 (83) 24 (77) Afri
Slide 34: Instillation and Injection Reduced Pain Equally Well
Instillation and Injection Reduced Pain Equally Well 140 121.6 120 100 86.2 85.2 Mean SPI0-24 80 60 40 20 0 HTX-011B 400mg Injection HTX-011B 400mg Instillation Saline Placebo (N=31) (N=14) (N=16) 34
Slide 35: HTX-011: Instillation Is Easier and Potentially Safer
HTX-011: Instillation Is Easier and Potentially Safer • Compared to injection, instillation into the incision site is: • Easier to administer and less invasive, avoiding up to 10 or more injections into the skin with large operations 35 • Safer, reducing the risk of venous puncture
Slide 36: Study 202: Mean Pain Intensity Scores
Study 202: Mean Pain Intensity Scores HTX-011B 400mg Significantly Better than Placebo Through 48 hours 8 SPI24-48 7 p=0.138 6 Mean Pain Intensity 5 4 3 2 1 SPI0-24 SPI0-48 SPI0-72 SPI0-96 p=0.0035 p=0.025 p=0.082 p=0.120 0 0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 90 96 HTX-011B 200mg HTX-011B 400
Slide 37: Study 202: Secondary Endpoints - Percent of Patients Requiring No Opioid
Study 202: Secondary Endpoints – Percent of Patients Requiring No Opioid Substantially Increased Consistent with the significant reductions in pain observed with HTX-011B, opiate use was also reduced: • Percent of patients who required no opioid rescue medication for the 96 hour study period substan
Slide 38: Summary of Treatment-Emergent Adverse Events in Study 202
Summary of Treatment-Emergent Adverse Events (TEAEs) in Study 202* HTX-011B 200 mg HTX-011B 400 mg Preferred Term Saline Placebo (N=31) (N=31) (N=30) Any TEAE 12 (38.7%) 10 (33.3%) 16 (51.6%) >1 TEAE in any treatment arm Nausea 2 (6.5%) 5 (16.7%) 4 (12.9%) Headache 3 (9.7%) 3 (10.0%) 0 Constipation
Slide 39: Phase 3 Program Designed to Demonstrate HTX-011's Broad Utility
Phase 3 Program Designed to Demonstrate HTX-011’s Broad Utility and Clear Advantage over Standard of Care • Heron’s Phase 3 program for HTX-011 will: – Include multiple types of surgical procedures – Compare HTX-011 not only to placebo but also to bupivacaine solution, the current standard of care f
Slide 40: HTX-011's Emerging Profile
HTX-011’s Emerging Profile • In clinical studies, HTX-011 has been shown to: – Significantly reduce pain for several days after surgery – Significantly reduce opioid use: • Reduced total amount of opioids consumed • Increased number of patients who NEVER need an opioid – Demonstrate these benefits v
Slide 41: Financial Summary
Financial Summary Summary Statement of Operations Nine Months Ended (In thousands, except per share data) September 30, 2016 Revenue $ – Operating expenses 124,112 Other expenses, net (1,068) Net loss $ (125,180) Net loss per share1 $ (3.34) Condensed Balance Sheet Data September 30, 2016 (In thousa
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